A Long-Term Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)

NCT ID: NCT07156578

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-10

Study Completion Date

2028-04-15

Brief Summary

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This is a long-term, open-label extension study of bivamelagon in participants with Hypothalamic Obesity (HO) who have transitioned from the index study, LG-MCCL005. The study will last up to 2 years.

Detailed Description

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Conditions

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Hypothalamic Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bivamelagon (open-label)

Group Type EXPERIMENTAL

Bivamelagon

Intervention Type DRUG

daily dose of oral bivamelagon

Interventions

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Bivamelagon

daily dose of oral bivamelagon

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Completed LG-MCCL005 and participant demonstrated adequate safety and tolerability in that study as determined by the Investigator.
* Agree to use a highly effective form of contraception and follow contraception requirements throughout the study and for 90 days after.

Exclusion Criteria

* Willing to remain off of: CYP3A4 inhibitors, strong CYP3A4 inducers, and P-glycoprotein inhibitors or substrates for the duration of the study.
* In the opinion of the Investigator, participant is not suitable to participate in the study.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rhythm Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Meeker, MD

Role: STUDY_CHAIR

Rhythm Pharmaceuticals, Inc.

Locations

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Children's Hospital Colorado

Aurora, Colorado, United States

Site Status

University of Iowa Children's Hospital

Iowa City, Iowa, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Columbia University

New York, New York, United States

Site Status

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status

Birmingham Women's and Children's NHS Foundation Trust

Birmingham, , United Kingdom

Site Status

University of Cambridge

Cambridge, , United Kingdom

Site Status

Great Ormond Street Hospital for Children

London, , United Kingdom

Site Status

Countries

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United States United Kingdom

Other Identifiers

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RM-MC72-002

Identifier Type: -

Identifier Source: org_study_id